NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT01894061|
Recruitment Status : Recruiting
First Posted : July 9, 2013
Last Update Posted : January 3, 2019
NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells.
The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.
|Condition or disease||Intervention/treatment||Phase|
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor||Biological: Bevacizumab Device: NovoTTF-l00A Other: Quality of Life Assessment||Phase 2|
This will be an open label Phase II trial in adults with recurrent glioblastoma (GBM). The NovoTTF-100A treatment and Bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment will be initiated in the outpatient clinic.
I. To determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive patients with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).
I. To assess safety and tolerability of the combination of bevacizumab and Novo-TTF-100A in this patient population.
II. To evaluate overall survival in this population. III. To determine objective response rate (ORR) by modified Revised Assessment in Neuro-Oncology (RANO) criteria in this population.
IV. To assess time-to-progression in this population. V. To assess neurocognitive function (NCF) and quality of life (QOL) in this population.
Patients receive bevacizumab intravenously (IV) on days 1 and 15. Patients also undergo electric field therapy with NovoTTF-100A for at least 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 28 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma|
|Actual Study Start Date :||June 12, 2013|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Bevacizumab and NovoTTF-100A
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
NovoTTF-100A will be worn continuously.
Other Name: electric field therapy
Other: Quality of Life Assessment
Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
Other Name: FACT-Br questionnaire
- Progression Free Survival (PFS) [ Time Frame: 6 months ]Number of patients that achieve progression free survival by Kaplan Meier methodology.
- Objective response rate based on RANO Criteria [ Time Frame: 30 days after treatment completion ]Response will be scored based on a combination of imaging and clinical features as defined by the modified Response Assessment in Neuro-Oncology (RANO) criteria. http://www.iconplc.com/services/imaging/central-imaging-core-lab-/regulatory-expertise/IMI-RANO-Criteria-Booklet-Nov-2011.pdf
- Number of patients that experience toxicities with this combination of therapies [ Time Frame: 30 days after treatment completion ]Safety and tolerability of combination of bevacizumab and NovoTTF-l00A in this population by CTCAE version 4.0.
- Median overall survival [ Time Frame: 30 days after treatment completion ]
- To assess time-to-progression [ Time Frame: 30 days after treatment completion ]Median time to progression by Kaplan Meier methodology.
- Neurocognitive function (NCF) [ Time Frame: 30 days after treatment completion ]Time to reliable change (decline) in neurocognitive function by Kaplan Meier methodology. Memory, verbal fluency, visual-motor speed, executive function and motor dexterity tests will be administered.
- Quality of Life (QOL) [ Time Frame: 30 days after treatment completion ]Based on the Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894061
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Rekha Chaudhary, MD 513-584-7698|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center||Active, not recruiting|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Manmeet Ahluwalia, MD 216-444-6145 firstname.lastname@example.org|
|Principal Investigator: Manmeet Ahluwalia, MD|
|Study Chair:||Manmeet Ahluwalia, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|